Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative
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AHWP Safety Alert Dissemination System (SADS)
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Guidance document on Risk Categorisation of Software as a Medical Device
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Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device”
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Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
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